Does poor glycaemic control affect the immunogenicity of the <scp>COVID‐19</scp> vaccination in patients with type <scp>2</scp> diabetes: The <scp>CAVEAT</scp> study

Marfella, Raffaele; D’Onofrio, Nunzia; Sardu, Celestino; Scisciola, Lucia; Maggi, Paolo; Coppola, Nicola; Romano, Ciro; Messina, Vito; Turriziani, Fabrizio; Siniscalchi, Mario; Maniscalco, Mauro; Boccalatte, Marco; Napolitano, Giovanni; Salemme, Luigi; Marfella, Ludovica Vittoria; Basile, Eugenio; Montemurro, Maria Vittoria; Papa, Carmela; Frascaria, F; Papa, A.; Russo, Filippo; Tirino, Virginia; Papaccio, Gianpaolo; Galdiero, Marilena; Sasso, Ferdinando Carlo; Barbieri, Michelangela; Rizzo, Maria Rosaria; Balestrieri, Maria Luisa; Angelillo, Italo Francesco; Napoli, Claudio; Paolisso, Giuseppe

doi:10.1111/dom.14547

Cited by 87 publications

(103 citation statements)

References 19 publications

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“…These results are in contrast with an observational study (CAVEAT study) that reported a lower antibody response to COVID-19 vaccination in people with type 2 DM having an HbA1c above 53 mmol/mol (7.0%) compared with normoglycemic individuals [16]. Nevertheless, people with DM in our study had a mean HbA1c of 51 mmol/mol (6.8%), hence, the differences might be attributed to the different glycemic status of the participants.…”

Section: Discussioncontrasting

confidence: 99%

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

et al. 2022

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The mRNA-based BNT162b2 vaccine has demonstrated high efficacy against severe SARS-CoV-2. However, data regarding immune response in people with diabetes mellitus (DM) after vaccination with the BNT162b2 vaccine are limited. In this prospective observational study, we examined humoral immune response in participants with and without DM after vaccination with the BNT162b2 mRNA vaccine. A total of 174 participants (58 with and 116 without diabetes, matched for age) were included. Antibodies were measured 21 days after the first dose, 7–15 days after the second dose, and 70–75 days after the second and before the third dose of the vaccine. Antibodies were measured by an anti-SARS-CoV-2 receptor-binding domain IgG (Abs-RBD-IgG) assay by a chemiluminescent microparticle immune assay; values > 50 AU/mL are considered protective from severe disease. Almost 17% of participants with DM did not develop adequate humoral immune response to the BNT162b2 mRNA vaccine after the first dose; however, it was high and similar after the second dose in both participants with and without DM and remained so almost 2 months after the second dose of the vaccine. Geometric mean values of Abs-RBD-IgG were not significantly different between participants with and without DM during the study. At least two doses of the BNT162b2 vaccine are necessary to ensure adequate and sustainable immune response in people with DM.

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Section: Discussioncontrasting

confidence: 99%

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

et al. 2022

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“…Current evidence suggests that glycemic control strongly impacts the efficiency of the immune response in patients receiving an mRNA vaccination against SARS-CoV-2 [ 61 ]. Indeed, hyperglycemia at the time of vaccination worsens the immunological response, as assessed by the abundance of SARS-CoV-2-neutralizing antibodies and of CD4+ T cells secreting immunomodulatory cytokines after specific stimulation with virus-relevant antigens [ 61 ]. On the other hand, the immunological response could be improved by achieving adequate glycemic control during the post-vaccination period [ 61 ].…”

Section: Vaccination Against Sars-cov-2: Effects In Patients With Dia...mentioning

confidence: 99%

“…Indeed, hyperglycemia at the time of vaccination worsens the immunological response, as assessed by the abundance of SARS-CoV-2-neutralizing antibodies and of CD4+ T cells secreting immunomodulatory cytokines after specific stimulation with virus-relevant antigens [ 61 ]. On the other hand, the immunological response could be improved by achieving adequate glycemic control during the post-vaccination period [ 61 ]. Therefore, stringent glycemic control might improve or even restore a proper immune response to SARS-CoV-2 vaccine [ 42 , 60 , 61 ].…”

Section: Vaccination Against Sars-cov-2: Effects In Patients With Dia...mentioning

confidence: 99%

Effect of Hyperglycemia on COVID-19 Outcomes: Vaccination Efficacy, Disease Severity, and Molecular Mechanisms

Sardu

Marfella

Prattichizzo

et al. 2022

JCM

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Background/Aims: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-stranded single-stranded RNA virus, a member of the subgenus Sarbecovirus (beta-CoV lineage B) and responsible for the coronavirus disease 2019 (COVID-19). COVID-19 encompasses a large range of disease severity, from mild symptoms to severe forms with Intensive Care Unit admission and eventually death. The severe forms of COVID-19 are usually observed in high-risk patients, such as those with type two diabetes mellitus. Here, we review the available evidence linking acute and chronic hyperglycemia to COVID-19 outcomes, describing also the putative mediators of such interactions. Findings/Conclusions: Acute hyperglycemia at hospital admission represents a risk factor for poor COVID-19 prognosis in patients with and without diabetes. Acute and chronic glycemic control are both emerging as major determinants of vaccination efficacy, disease severity and mortality rate in COVID-19 patients. Mechanistically, it has been proposed that hyperglycemia might be a disease-modifier for COVID-19 through multiple mechanisms: (a) induction of glycation and oligomerization of ACE2, the main receptor of SARS-CoV-2; (b) increased expression of the serine protease TMPRSS2, responsible for S protein priming; (c) impairment of the function of innate and adaptive immunity despite the induction of higher pro-inflammatory responses, both local and systemic. Consistently, managing acute hyperglycemia through insulin infusion has been suggested to improve clinical outcomes, while implementing chronic glycemic control positively affects immune response following vaccination. Although more research is warranted to better disentangle the relationship between hyperglycemia and COVID-19, it might be worth considering glycemic control as a potential route to optimize disease prevention and management.

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“…Clinical data have shown a robust neutralizing antibody response in patients with diabetes [38]. However, recent data have shown that hyperglycemia at the time of COVID-19 vaccination worsens the immune response, whereas achieving adequate glycemic control during the post-vaccination period improves the immune response [39]. Therefore, we need to focus on achieving good glycemic control, which can play a role in clinical COVID-19 outcomes and vaccine efficiency Table 1.…”

Section: Effects On Diabetes Of the Restrictions Arising From The Covid-19 Pandemicmentioning

confidence: 99%

COVID-19 and Diabetes

Bellido

Pérez

2021

JCM

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Diabetes mellitus (DM) is one of the most common comorbid conditions in persons with COVID-19 and a risk factor for poor prognosis. The reasons why COVID-19 is more severe in persons with DM are currently unknown although the scarce data available on patients with DM hospitalized because of COVID-19 show that glycemic control is inadequate. The fact that patients with COVID-19 are usually cared for by health professionals with limited experience in the management of diabetes and the need to prevent exposure to the virus may also be obstacles to glycemic control in patients with COVID-19. Effective clinical care should consider various aspects, including screening for the disease in at-risk persons, education, and monitoring of control and complications. We examine the effect of COVID-19 on DM in terms of glycemic control and the restrictions arising from the pandemic and assess management of diabetes and drug therapy in various scenarios, taking into account factors such as physical exercise, diet, blood glucose monitoring, and pharmacological treatment. Specific attention is given to patients who have been admitted to hospital and critically ill patients. Finally, we consider the role of telemedicine in the management of DM patients with COVID-19 during the pandemic and in the future.

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Does poor glycaemic control affect the immunogenicity of the COVID‐19 vaccination in patients with type 2 diabetes: The CAVEAT study

Cited by 87 publications

References 19 publications

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

Immunogenicity of SARS-CoV-2 BNT162b2 Vaccine in People with Diabetes: A Prospective Observational Study

Effect of Hyperglycemia on COVID-19 Outcomes: Vaccination Efficacy, Disease Severity, and Molecular Mechanisms

COVID-19 and Diabetes

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